4. Matters Arising

The SMC advice for apixiban (Eliquis), for prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery, will be published on the SMC website on Monday, 12 December 2011.

The SMC advice for telaprevir (Incivo), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis) who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders, will be published on the SMC website on Monday, 12 December 2011.

The SMC advice for telaprevir (Incivo), in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis) who are treatment naïve, will be published on the SMC website on Monday, 12 December 2011.

The SMC advice for dexamethasone (Ozurdex), for the for the treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO), will be published on the SMC website on Monday, 12 December 2011.

NON Submission

4.5 denosumab (Xgeva®) Amgen Ltd SMC No.(752/11)

The SMC advice for denosumab (Xgeva®), for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours, will be published on the SMC website on Monday, 12 December 2011.

Deferred Advice

4.6 Nothing to report.

Amended Advice

4.7 Nothing to report.

5. Appeals Update

In November 2011, SMC considered but did not recommend a submission for dexamethasone 700 microgram intravitreal implant (Ozurdex®), for the treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). In two phase III studies dexamethasone 700 microgram intravitreal implant was superior to sham administration at day 90 for the proportion of patients with a best corrected visual acuity improvement of =15 letters. Longer-term effectiveness of treatment is uncertain. The submitting company did not provide a sufficiently robust clinical and economic analysis to gain acceptance by SMC. The licence holder has intimated their intention to make a resubmission.

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Update

Mrs Anne Murray reported that up until now PAPIG have focused on Patient Interest Groups and patients but now wish to look at the public dimension. The Chairman advised that this is reflected in the SMC response to the Public Petitions Committee and it would be helpful to have a public perspective of new medicines for SMC.

The new template for Patient Interest Group Submissions is being piloted and PAPIG intend to send a questionnaire to SMC members to ascertain their opinion on the new template before it is progressed further.

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 Secure Site

The Chairman reported that from January, 2012, paperwork would be available via the web-enabled access only. She thanked members for their useful feedback during the pilot phase and advised that, where possible, the site had been modified and enhanced to reflect feedback. She advised that a review will take place after 3 months to determine if any other improvements require to be made.

9. NDC ASSESSMENT REPORTS

9.1.1 A member with a personal specific interest left the meeting for this part of the agenda.

9.1.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company. Detailed discussion followed and the group agreed that linagliptin film-coated tablet (Trajenta®), should be accepted for restricted use within NHS Scotland.

Indication under review: The treatment of type 2 diabetes mellitus to improve glycaemic control in adults:
As monotherapy

in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contra-indicated due to renal impairment

As combination therapy

in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control

in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control

SMC restriction: in combination therapy with metformin when diet and exercise plus metformin alone does not provide adequate glycaemic control in patients for whom the addition of a sulphonylurea is inappropriate.

In two randomised double-blind, controlled studies, linagliptin in combination with metformin was found to be non-inferior to a sulphonylurea plus metformin, and superior to placebo plus metformin in controlling glycaemia, measured by the change in glycosylated haemoglobin (HbA1c). Linagliptin was associated with similar rates of hypoglycaemia and changes in weight when compared with placebo. Linagliptin is one of a number of medicines in this class, some of which are available at a lower acquisition cost.

SMC cannot recommend the use of linagliptin as monotherapy or in combination with metformin and a sulphonylurea as the company’s submission related only to its use in combination with metformin.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 December 2011.

9.2.1 Declarations of interest were recorded in relation to this product/comparator drugs. A member with a personal specific interest left the meeting for this part of the agenda.

The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company. A member of PAPIG presented a patient interest group submission from Diabetes UK Scotland. Detailed discussion followed and the group agreed that exenatide once weekly (Bydureon®), should be accepted for restricted use within NHS Scotland.

in adults who have not achieved adequate glycaemiccontrol on maximally tolerated doses of these oral therapies.

SMC restriction: Exenatide once weekly is restricted to use as a third line treatment option. The economic case for exenatide once weekly for second line use in combination with metformin in place of a sulphonylurea has not been made.

In four randomised comparative studies in patients with type II diabetes and receiving oral anti-diabetic agents and/or diet and exercise regimens, exenatide once weekly was superior to the comparators for change in HbA1c. However in a fifth study exenatide once weekly was not superior to another glucagon-like peptide-1 receptor agonist.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 December 2011.

9.3.1 There were no declarations of interest recorded in relation to this product/comparator drugs.

9.3.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company. Detailed discussion followed and the group agreed that entecavir (Baraclude®), should not be recommended for use within NHS Scotland.

Entecavir demonstrated a superior virological response in adults with chronic HBV and decompensated liver disease compared with another nucleoside/nucleotide analogue. However there is no comparative evidence versus the relevant comparator.

The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 December 2011.

9.4.1 There were no declarations of interest recorded in relation to this product/comparator drugs.

9.4.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company. A member of PAPIG presented a patient interest group submission from The Roy Castle Lung Cancer Foundation. Detailed discussion followed and the group agreed that erlotinib (Tarceva®), should be accepted for use within NHS Scotland.

In patients with advanced or metastatic NSCLC with EGFR mutations, erlotinib was associated with significantly improved progression-free survival compared with platinum-based doublet chemotherapy regimens. There are no mature overall survival data.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of erlotinib. This SMC advice is contingent upon the continuing availability of the PAS in NHS Scotland.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 December 2011.

9.5.1 There were no declarations of interest recorded in relation to this product/comparator drugs.

9.5.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company. Detailed discussion followed and the group agreed that ranolazine (Ranexa®), should not be recommended for use within NHS Scotland.

Indication under review: as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).

When added to standard doses of antianginal drugs, ranolazine increased exercise duration at trough drug levels compared with placebo after 12 weeks treatment. Although significant the effect size was modest.

The submitting company did not present a sufficiently robust clinical and economic case to gain acceptance by SMC.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 December 2011.

9.6.1 A member with a personal specific interest left the meeting for this part of the agenda.

9.6.2 Dr L Sillito provided an overview of the assessment. Detailed discussion followed and the group agreed that fentanyl single dose nasal spray (Instanyl®), should be accepted for restricted use in NHS Scotland.

Indication under review: for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.

Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

SMC restriction: to patients who are unsuitable for other short-acting oral opioids (e.g. oral morphine) as an alternative to other buccal and sublingual fentanyl preparations. It should be noted that the doses of fentanyl nasal spray are significantly lower than doses of fentanyl given by other routes of administration for this indication.

In a pharmacokinetic study in healthy volunteers, this single dose fentanyl nasal spray presentation was shown to be bioequivalent to the multi-dose nasal spray presentation and is available at equivalent cost per dose.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 December 2011.

9.7.1 In the absence of a submission from the holder of the marketing authorization dexamethasone (Ozurdex ®) 0.7 mg intravitreal implant, should not be recommended for use within NHS Scotland, for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis.

9.7.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 December 2011.

10. SMC User Group Forum

10.1 Update from UGF Meeting

Nothing to report.

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted.

12. Area Drug & Therapeutics Committee (ADTC) Issues

12.1 Nothing to report.

13. Any Other Business

13.1 SMC Meeting in June 2012

The Chairman advised that there will be a special bank holiday in 2012 to celebrate the Queen's Diamond Jubilee. The 2012 late May bank holiday will be moved to Monday 4 June 2012 and an additional Jubilee bank holiday will be on Tuesday 5 June 2012. In view of this it is proposed to change the SMC meeting scheduled for Tuesday 5 June to Wednesday 6 June, 2012 to accommodate the bank holiday. If this date should be unsuitable can you please contact the Secretariat as soon as possible to advise.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 10 January 2012 at 12.30 pm (lunch from 12 noon), in Healthcare Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

NICE Publications

Minutes of the SMC Meeting 06 December 2011

There were no NICE publications reported at the SMC meeting of 06 December 2011.